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布瓦西坦:部分性发作的辅助治疗药物。

Brivaracetam: An Adjunctive Treatment for Partial-Onset Seizures.

作者信息

Kappes John A, Hayes William J, Strain Joe D, Farver Debra K

机构信息

Department of Pharmacy Practice, South Dakota State University, College of Pharmacy, Rapid City Regional Hospital, Rapid City, SD, USA.

Department of Pharmacy Practice, South Dakota State University, College of Pharmacy, VA Black Hills Health Care System, Fort Meade, SD, USA.

出版信息

J Clin Pharmacol. 2017 Jul;57(7):811-817. doi: 10.1002/jcph.900. Epub 2017 Apr 10.

Abstract

Brivaracetam is an analogue of levetiracetam that is Food and Drug Administration-approved for adjunctive treatment of partial-onset seizures in patients 16 years and older. In placebo-controlled trials adjunct brivaracetam demonstrated efficacy in reducing the frequency of seizures. The most commonly reported adverse effects are somnolence, dizziness, and fatigue. Clinical trials have evaluated brivaracetam for safety and efficacy in adjunctive treatment of partial-onset seizures in patients 16 years and older for up to 16 weeks. Brivaracetam's mechanism is similar to that of levetiracetam but with greater receptor binding affinity on synaptic vesicle protein 2A and inhibitory effects on sodium channels. Clinically significant differences between these agents are undetermined. Brivaracetam is available as oral tablets, oral solution, and intravenous solution. The Food and Drug Administration-approved dose is 50 mg twice daily, and titration is not required. Brivaracetam does not need dose adjustment for renal impairment and has minimal drug-drug interactions. Current limitations of brivaracetam include lack of head-to-head trials, limited long-term safety and efficacy data, and cost. Overall, brivaracetam is a viable adjunct therapeutic option for refractory partial-onset seizures in those who have failed conventional therapies.

摘要

布瓦西坦是左乙拉西坦的类似物,已获美国食品药品监督管理局批准,用于辅助治疗16岁及以上患者的部分性发作。在安慰剂对照试验中,辅助使用布瓦西坦可有效降低癫痫发作频率。最常报告的不良反应为嗜睡、头晕和疲劳。临床试验评估了布瓦西坦在16岁及以上患者辅助治疗部分性发作长达16周的安全性和有效性。布瓦西坦的作用机制与左乙拉西坦相似,但对突触囊泡蛋白2A具有更高的受体结合亲和力,并对钠通道有抑制作用。这些药物之间的临床显著差异尚未确定。布瓦西坦有口服片剂、口服溶液和静脉溶液剂型。美国食品药品监督管理局批准的剂量为每日两次,每次50毫克,无需滴定。布瓦西坦无需因肾功能损害调整剂量,药物相互作用极少。布瓦西坦目前的局限性包括缺乏头对头试验、长期安全性和有效性数据有限以及费用问题。总体而言,对于传统疗法无效的难治性部分性发作患者,布瓦西坦是一种可行的辅助治疗选择。

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